process validation engineer

We are seeking a highly skilled Process Validation Engineer to join our Manufacturing Engineering Team based nearSouthend-on-Sea, UK. This pivotal role involves owning all aspects of process validation within the manufacturing environment, ensuring our processes are fully validated for production use in strict compliance with regulatory standards.Responsibilities

As the Process Validation SME, you will be responsible for ensuring the validation of manufacturing processes, focusing on regulatory compliance, process integrity, and continuous improvements.Validation Leadership: Take the lead in the creation and execution of the Site Master Validation Plan. This includes planning, developing risk-based protocols, and overseeing specific validation activities while also supporting and guiding validation efforts carried out by other engineers.Project Support & Process Enhancement: Collaborate with project teams and production departments to provide process validation expertise for development projects, continuous improvement initiatives, and change management activities.Regulatory Guidance: Offer expert advice on process validation, ensuring compliance with relevant regulatory standards. Your input will be crucial in maintaining the quality and compliance of manufacturing processes.Documentation & Approvals: Lead the creation of risk-based validation protocols, reviewing and approving validation documentation. You will be responsible for ensuring all documentation meets the necessary quality and regulatory standards.Coaching & Knowledge Sharing: Provide coaching and mentoring to less experienced engineers, fostering a collaborative environment that promotes knowledge sharing and team development.Statistical Methods: Apply statistical tools and techniques within validation activities to ensure processes are verified and validated accurately and effectively.Audit Representation: Represent the Process Validation function during both internal and external audits, ensuring that validation processes meet all regulatory requirements and industry standards.What do we need from you?

Educational Background: Minimum of HNC or higher in an Engineering discipline (Mechanical, Electrical, Manufacturing, or a related field).Relevant Experience: Proven track record in an engineering or manufacturing environment, with deep expertise in process validation. You should have experience in planning, creating, executing, and maintaining validation protocols.Technical Expertise: Strong technical skills, including the ability to interpret engineering drawings. Proficiency in Microsoft Office and a strong understanding of statistical methods for process validation are essential.Communication Skills: Excellent written and verbal communication skills, with the ability to clearly articulate complex technical concepts to both technical and non-technical stakeholders.Team Collaboration: A proactive and collaborative approach, with the ability to work independently as well as part of a team.Package

Up to £60,000 basic salary with flexibility for exceptional candidates.Relocation Assistance: Reimbursement scheme available for relocation costs (up to £12,000).Generous Benefits:26 days of annual leave plus bank holidays.Defined contribution pension scheme with employer match up to 12%.Private medical and dental coverage (optional participation).Annual health checks, employee assistance programs, and discounted gym memberships.Enhanced parental leave.Subsidised on-site staff restaurant.

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